Floatation-REST in Methamphetamine Use Disorder: A Pilot Study

NCT05799209 | Unknown FDA Device

• 1 other identifier: 2022-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 50 individuals receiving treatment for Amphetamine-Type Substance Use Disorder.

Conditions

Amphetamine-Type Substance Use Disorder

Keywords

Methamphetamine Use Disorder; Floatation Therapy

Outcome Measures

Primary Outcomes (1)

• Side Effects

  As a proxy of safety, the negative and positive side effects reported by each participant is equal to the number of instances during the study when a participant reports elevations above mild for any negative or positive effects on the side effect checklist (administered after each float session)

  Over the span of the intervention, up to two weeks

Secondary Outcomes (10)

• Completion Rate

  Over the ten days of intervention

• Stimulant Craving on the Stimulant Craving Questionnaire (STCQ)-Brief

  Through completion of the final float session, up to two weeks

• State Anxiety on the State Trait Anxiety Inventory (STAI)

  Through completion of the final float session, up to two weeks

• Negative Affect on Positive and Negative Affective Schedule- X

  Through completion of the final float session, up to two weeks

• Positive Affect on Positive and Negative Affective Schedule- X

  Through completion of the final float session, up to two weeks

Study Arms (2)

Reduced Environmental Stimulation Pool

EXPERIMENTAL

floating supine in a pool for a prescribed amount of time (1 total session lasting 1 hour)

Device: Float Pool

Zero Gravity Chair

ACTIVE COMPARATOR

floating supine in a zero-gravity chair for a prescribed amount of time (1 total session lasting 1 hour)

Device: Float Chair

Interventions

Float Pool DEVICE

Participant floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Reduced Environmental Stimulation Pool

Float Chair DEVICE

Participant floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Zero Gravity Chair

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-55 years of age
• Meeting criteria for a primary DSM-5 diagnosis of current methamphetamine use disorder
• Has completed at least two weeks of inpatient treatment (translating into having at least two weeks of drug/alcohol sobriety) at one of the two recruitment sites (Grand Addiction and Recovery Center or Women In Recovery) and is still currently enrolled in this treatment at the time of the study
• Capable of completing all measures during each session of the experiment: able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.

You may not qualify if:

• Has any of the following DSM-5 disorders: Schizophrenia Spectrum and Other Psychotic Disorders OR Bipolar I Disorder
• Participant fails to adhere to our "Pre-float checklist".
• Any antihistamine that causes drowsiness (e.g., Benadryl).
• Caffeine or nicotine consumed within the past 2 hours.
• Reports a history of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
• A breathalyzer test positive for alcohol or a drug-positive urine test at either session.
• Non-correctable vision or hearing problems.
• Unwillingness or inability to complete major aspects of the study protocol (e.g., floating). However, failing to complete some individual aspects will be acceptable (e.g., being unwilling to answer individual items on a questionnaire).

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

RECRUITING

Central Study Contacts

Sahib Khalsa, MD, PhD

CONTACT

918-240-2583; skhalsa@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigator and participant are masked to study arm until after the participant completes their baseline assessment visit, at which point they are randomized using a sealed envelope.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants complete both arms of the study on separate days.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 5, 2023
• Study Start: March 15, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)